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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12605000081617
Ethics application status
Approved
Date submitted
31/07/2005
Date registered
5/08/2005
Date last updated
5/04/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
HATS trial
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Scientific title
Hand-assisted thoracoscopic surgery versus Limited thoracotomy: Randomised controlled trial comparing early post-operative quality of life after diagnostic lung biopsy and radical metastasectomy
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Secondary ID [1]
291626
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
HATS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
1. Undiagnosed pulmonary nodules not accessible by VATS.
158
0
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2. Pulmonary metastases suitable for wedge resection.
159
0
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Condition category
Condition code
Cancer
177
177
0
0
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Access to the lung using thoracoscope and trans-diaphragmatic palpation via small subcostal incision. Compared with smallest practical thoracotomy incision to acheive same lung resection.
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Intervention code [1]
79
0
Treatment: Surgery
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Comparator / control treatment
Limited thoracotomy
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Control group
Active
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Outcomes
Primary outcome [1]
214
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Quality of life scores (SF-12v2)
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Assessment method [1]
214
0
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Timepoint [1]
214
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14 and 42 days post surgery
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Secondary outcome [1]
490
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Pain scores
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Assessment method [1]
490
0
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Timepoint [1]
490
0
In 24 hours after epidural removal.
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Secondary outcome [2]
491
0
Ipsilateral lung recurrence of pulmonary metastases.
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Assessment method [2]
491
0
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Timepoint [2]
491
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2 years
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Secondary outcome [3]
492
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Respiratory function.
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Assessment method [3]
492
0
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Timepoint [3]
492
0
6 months
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Secondary outcome [4]
493
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Diaphragm function.
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Assessment method [4]
493
0
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Timepoint [4]
493
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6 months
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Secondary outcome [5]
494
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Wound complications.
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Assessment method [5]
494
0
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Timepoint [5]
494
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30 days
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Eligibility
Key inclusion criteria
Consenting adult requiring either diagnosis of lung nodule or clearance of pulmonary metastases from sarcoma, colorectal or renal carcinoma, melanoma or germ cell tumour. Must be amenable to wedge resection. Must have PET scan to exclude extra-thoracic disease and confirm primary site control.
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Minimum age
18
Years
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Independently held codes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Stratified for indication.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2001
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Actual
23/10/2001
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Date of last participant enrolment
Anticipated
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Actual
4/05/2005
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Date of last data collection
Anticipated
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Actual
3/05/2010
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Sample size
Target
60
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
233
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University
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Name [1]
233
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University grant
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Address [1]
233
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Faculty of Medicine, Dentistry and Health Sciences University of Melbourne
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Country [1]
233
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Australia
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Primary sponsor type
Individual
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Name
Gavin M Wright
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Address
Cardiothoracic Research Office
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
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Country
Australia
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Secondary sponsor category [1]
173
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Individual
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Name [1]
173
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Joseph M Paiva
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Address [1]
173
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Cardiothoracic Research Office St Vincent's Hospital 41 Victoria Parade Fitzroy VIC 3065
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Country [1]
173
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
1031
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St Vincent's Hospital, Melbourne
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Ethics committee address [1]
1031
0
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Ethics committee country [1]
1031
0
Australia
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Date submitted for ethics approval [1]
1031
0
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Approval date [1]
1031
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01/10/2001
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Ethics approval number [1]
1031
0
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Ethics committee name [2]
1032
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St Vincent's and Mercy Private Hospital
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Ethics committee address [2]
1032
0
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Ethics committee country [2]
1032
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Australia
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Date submitted for ethics approval [2]
1032
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Approval date [2]
1032
0
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Ethics approval number [2]
1032
0
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Summary
Brief summary
To determine whether a new form of minimally invasive ("keyhole") surgery results in less pain and suffering than traditional surgery of the lung via thoracotomy.
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Trial website
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Trial related presentations / publications
1. Paiva JM, Wright GM. Hand assisted thoracoscopic surgery causes less postoperative pain than limited thoracotomy after cessation of epidural analgesia. Heart Lung Circ 2004; 13: 374-8. 2. Wright GM, Clarke CP, Paiva J. How to do it: Hand Assisted Thoracoscopic Surgery. Ann Thorac Surg 2003; 75: 1665-7. 3. Wright GM, Long H, Hand-assist VATS: minimum invasion, maximum return, ANZ J Surg 2001; 71 (s1): A17 4. Dear RF, Kelly PJ, Wright GM, Stalley P, McCaughan BC, Tattersall MHN. Pulmonary metastasectomy for bone and soft tissue sarcoma in Australia: 114 patients from 1978 to 2008. Asia Pac J Clin Oncol 2012; 10.1111/j.1743-7563.2012.01521.x
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Public notes
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Contacts
Principal investigator
Name
35815
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A/Prof Gavin M Wright
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Address
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Cardiothoracic Research Office St Vincent's Hospital 41 Victoria Parade Fitzroy VIC 3065
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Country
35815
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Australia
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Phone
35815
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+61 3 9419 2477
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Fax
35815
0
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Email
35815
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[email protected]
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Contact person for public queries
Name
9268
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Gavin M Wright
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Address
9268
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St Vincents's Hospital Melbourne 5th Floor 55 Victoria Parade Fitzroy VIC 3065
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Country
9268
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Australia
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Phone
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+61 3 94192477
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Fax
9268
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+61 3 94171694
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Email
9268
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[email protected]
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Contact person for scientific queries
Name
196
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Gavin M Wright
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Address
196
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St Vincents's Hospital Melbourne 5th Floor 55 Victoria Parade Fitzroy VIC 3065
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Country
196
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Australia
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Phone
196
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+61 3 94192477
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Fax
196
0
+61 3 94171694
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Email
196
0
[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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